Senior Manager, Global Clinical Regulatory Lead
PTC Therapeutics, Inc.
August 25, 2026
Remote friendly (New Jersey, United States)
United States
Clinical Research and Development
Job Responsibilities:
- Provide strategic and operational direction for planning, management, support, and execution of regulatory activities for PTC drug products (clinical and commercial) in the US (as applicable).
- Support global clinical trials, regional registrations, and life cycle management regulatory activities; support the Global Regulatory Lead (GRL) on assigned products.
- Oversee IND submissions in the US and clinical trial applications for the rest of world; support GRL to ensure regional regulatory strategies comply with applicable regulations/standards.
- Collaborate with Regulatory Affairs Strategy team, regulatory subteams, cross-functional teams, Global Pharmacovigilance (PV), other departments, external service providers, and contract manufacturers.
- Ensure regional product distribution meets local regulatory requirements and relevant SOPs.
- Maintain regulatory knowledge and develop global regulatory strategies (including for drugs and gene therapies): research, labeling documents, and regulatory submissions.
- Prepare/review submissions (e.g., RPDD, ODD, Annual Reports, DSURs, Scientific Advice briefing books, pre-IND, IND, Briefing Books, MAA/BLA/NDAs) and prepare CCDS, US-PI, and SmPC.
- Initiate and execute CTA/CTNs in US/EU/globally; liaise with CROs/IRL/GRLs on timelines and manage health-authority interactions.
Qualifications:
- Bachelor’s in life sciences plus 5+ years in Pharma/Bio; MS/PhD/PharmD plus 3+ years in Regulatory Affairs.
- Knowledge of regional regulatory guidelines; ability to interpret for assigned projects.
- Hands-on experience managing/submitting clinical trial applications across development phases, including responses to health-agency queries.
- Ability to build cross-functional stakeholder relationships; excellent verbal/written communication.
- Independent and collaborative work in a matrix environment; strong analytical, problem-solving, planning/organizational/time-management skills.
- Ability to influence without direct authority; fluent in English (other languages a plus).
Travel: Up to 5%.
Location: Hybrid role in Warren, NJ.
- Provide strategic and operational direction for planning, management, support, and execution of regulatory activities for PTC drug products (clinical and commercial) in the US (as applicable).
- Support global clinical trials, regional registrations, and life cycle management regulatory activities; support the Global Regulatory Lead (GRL) on assigned products.
- Oversee IND submissions in the US and clinical trial applications for the rest of world; support GRL to ensure regional regulatory strategies comply with applicable regulations/standards.
- Collaborate with Regulatory Affairs Strategy team, regulatory subteams, cross-functional teams, Global Pharmacovigilance (PV), other departments, external service providers, and contract manufacturers.
- Ensure regional product distribution meets local regulatory requirements and relevant SOPs.
- Maintain regulatory knowledge and develop global regulatory strategies (including for drugs and gene therapies): research, labeling documents, and regulatory submissions.
- Prepare/review submissions (e.g., RPDD, ODD, Annual Reports, DSURs, Scientific Advice briefing books, pre-IND, IND, Briefing Books, MAA/BLA/NDAs) and prepare CCDS, US-PI, and SmPC.
- Initiate and execute CTA/CTNs in US/EU/globally; liaise with CROs/IRL/GRLs on timelines and manage health-authority interactions.
Qualifications:
- Bachelor’s in life sciences plus 5+ years in Pharma/Bio; MS/PhD/PharmD plus 3+ years in Regulatory Affairs.
- Knowledge of regional regulatory guidelines; ability to interpret for assigned projects.
- Hands-on experience managing/submitting clinical trial applications across development phases, including responses to health-agency queries.
- Ability to build cross-functional stakeholder relationships; excellent verbal/written communication.
- Independent and collaborative work in a matrix environment; strong analytical, problem-solving, planning/organizational/time-management skills.
- Ability to influence without direct authority; fluent in English (other languages a plus).
Travel: Up to 5%.
Location: Hybrid role in Warren, NJ.